PRAHS

  • TMF Coordinator - Boston, MA

    Job Locations (All) | US-MA-Boston
    Posted Date 4 days ago(12/12/2018 4:47 PM)
    ID
    2018-50728
  • Overview

    Who are we?

    We Are PRA. 

     

    We are over 15,000 employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. 

     

     Who are you? 

     

    You are the TMF subject matter expert in your field, and yet, people contact you with questions that fall outside your jurisdiction because they know you will leverage every resource you have to get them the answers they need.  You have excellent communication & follow-up skills, you dot your “i’s” and cross your “t’s,” and there’s just something about tasks that tap into your innate process orientation that make your heart go pitter-patter. With your commitment to executing projects in accordance with the highest standards, you hold a certain reverence for the regulatory processes, SOPs and document trails that map out a pathway to compliance. But most of all, you are someone with tremendous potential who wants to apply your many talents in a role that will expand your fundamental knowledge of clinical research and provide you with the options and training to continue to grow in your career. 

     

    Still here? Good. Because if this is you, we’d really like to meet you.

    Responsibilities

    What will you be doing?  

    In a nutshell, you will be the main contact for our Clients and Project Teams for various Document Management deliverables. You will answer questions, send out progress reports for your studies, be involved in audits, and ensure all PRA processes are followed, any study risks are mitigated, and any deliverables meet the expectations of PRA and our Clients. You are the expert on your assigned studies and have ownership for their success from start to finish.  The Trial Master File (TMF) Coordinator is responsible for collecting, developing and documenting the requirements for the TMF. To coordinate, monitor and report onkey TMF activities of the project team and other Document Management staff, including TMF Readiness Reviews and final delivery of the TMF. Provides project-specific oversight and training to other Document Management staff and serves as the main Document Management contact for internal and external customers.

     

    Qualifications

    What do you need to have?

    • Proficient working within a Microsoft Office Environment
    • Independent time management and problem-solving
    • Industry knowledge including ICH/GCP, local regulatory authority and clinical development regulations
    • Prior experience using computerized information systems
    • Prior experience in a leadership role
    • Proficient in developing project/process documents
    • Read, write and speak fluent English; fluent in host country language required
    • Some college coursework

    PREFERRED EXPERIENCE:

     

    • 0-3 years of Clinical, Quality, or Information Management experience preferred
    • Possess some general knowledge of clinical trials and basic principles, procedures, and common best practices
    • Strong command of Microsoft Office Suite
    • Demonstrates basic knowledge and understanding of applicable regulations
    • Demonstrates effective, self-sufficient communication skills
    • Displays good interpersonal skills and ability to deal with a variety of personnel 
    • Undergraduate degree preferred

     

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities. 
    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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